Pharmaceutical API and QA Consultant with Expertise in Steroids and Norsteroids Manufacturing. Lean Management, Validation, FDA InspectionsActive Pharmaceutical Ingredient (API) manufacturing and quality assurance, successful scale-up, technology transfer and quality assurance projects.Steroid plant operations; training, FDA inspections, and manufacturing.Lean management in API manufacturing.Quality assurance management; release operations in packaging processesAPI manufacturing - steroids and norsteroids.Pharmaceutical products scale-ups and technology transfers.Qualification of equipment (reactors, centrifuge, dryers etc.) and utilities,...

Ph.D. Consultant with expertise in Characterization and Quantitation of Proteins and Small Molecules. Subject Matter Expert (SME), Oversight (in-house-external) CRO support, and GLP/GMP.Analytical and bioanalytical methods for characterization and quantitation of drug therapeutics and pharmaceutical product development.Monitor analytical and bioanalytical activities at CROs in support of non-clinical and clinical trials.Characterization of small molecule, biologics (peptides, proteins, and antibodies), antibody drugs conjugates (ADCs), PEGylated proteins, and oligonucleotides.Drug Metabolism and Pharmacokinetics (DMP) parameters, basic no...

Pharmaceutical Operations - Small to Mid-Sized Companies, from Technology Transfer through Packaging and Distribution, and with Companies Under Regulatory or Financial DuressLife sciences manufacturing with specific focus to technology services, quality systems, engineering oversite, strategic and tactical planning strategies.Providing supply chain consulting and compliance achieving profitability goals, utilizing Lean Six Sigma.ServicesLean Six Sigma Black Belt.Pharmaceutical manufacturing.Pharmaceutical process engineering.Pharmaceutical continuous improvement.Quality engineering and quality systems.Quality Systems Implementation.Cont...

Senior Pharma Regulatory Consultant with Expertise in Strategic Planning, Development, US Regulatory Preparation, Documentation (IND ANDA, DMF, CTD) and Quality AssuranceExpediting pharmaceutical services in: Pharmaceutical regulatory, Quality Assurance (QA), global pharmaceutical support, investigational and drug development.Enhancement and development of regulatory affairs with an overall development of regulatory strategy for business models through evaluation and control of pipeline products for commercial and drug development venture companies.Building pharmaceutical regulatory departments and assessing their effectiveness in paralle...

Pharmaceutical Quality Assurance Quality Control expert with experience with U.S., E.U., Canada, and India regulationsPharmaceutical Quality Assurance and Regulatory Affairs.Compliance audit, Quality Operations and Regulatory Submissions.Design and implementation of Quality Systems and regulatory compliance programs.Domestic and international quality and regulatory compliance.Managing contract / vendor supply chain quality programs.Developing and delivering GMP, GDP, DI procedure training programs.Leading the Quality efforts to successfully remediate recurring failures.Generation, maintenance and revision of SOP's, specifications, procedur...

Pharmaceutical Product and Process Development, cGMP, cGLP, FDA, Regulatory, Research and Technology DevelopmentSummary Over 15 years of pharmaceutical industry acumen, new product development through life-cycle management (post-marketing support) process, with the ability to address regulatory requirements set forth by the FDA and other health authorities. Effective problem solver with the ability to apply technical expertise and solutions to diverse situations successfully. Analytical research and development in the pharmaceutical industry. Project management. Test method development. Process development. cGMP, cGLP, FDA, and ICH...

Pharmaceutical GMP Consultant with expertise in GMP, QMS, Documentation, Validations, Plant setup, Training and development, Quality control, Audits, environmental monitoring, for Solid orals, Liquid Sterile, solid orals, liquid orals, dermal products; various dosage forms. Managing strategic and operational performance of Quality Department providing: Development and implementation, Standardized quality system processes, Review of standards for quality control, Regulatory compliance, Quality control systems and procedures (GLP). Pharmaceutical industry (Formulations). Quality Management System (QMS); Complaints, recalls, deviati...

Expert in GMP requirements for software and equipment validationSpecializes in consulting and project management for Supervisory Control and Data Acquisition (SCADA), System Integration and Industrial Controls including pharmaceutical industry regulatory compliance, 21 CFR Part 11 and controls for clean rooms. Specific expertise in :Good Automated Manufacturing Practices (GAMP).21 CFR Part 11 Training. Computer Validation Training by PDA.PLC hardware and softwarePharmaceutical Current Good Manufacturing (cGMP) and validation of computer softwareGood Automated Manufacturing Practices (GAMP) and Good Electronic Records Management (GERM) me...

Regulatory Pharmaceutical Compliance Consultant with Expertise in Clinical, Pharmacovigilance, Biologics, Biosimilars, Orphan Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic, and Food.Regulatory strategy, pathways and gap analyses.Regulatory submissions and applications for diverse product types to global regulatory agencies: Health Canada, US FDA and EU EMA (CTA, IND, IDE, DMF, NDS, SNDS, ANDS, SANDS, DIN, NDA, NDA 505(b)(2), BLA, ANDA, PAS, CBE, CBE-30, 510(k), PMA, HUD, HDE, Class II, III and IV Device License Applications, ITA, MAA, Type I and II variations, Technical File, PLA, Amendments, Notifications, a...

Consultant with Diverse Pharmaceutical Experience in Formulation Development, Manufacturing, Technology and Site Transfer, Process Design, Scale-Up, and ValidationPharmaceutical formulation development, manufacturing technology transfer, site transfer, process design optimization, and scale-up for domestic and international clients.Product development using QbD approach, process scale-up and optimization, process validation.Drive technology platforms such as solid and Liquid orals, aseptic filling, softgels, orally disintegrating granules, powders, MR products, X-ray contrast media, peptide injectable product, topicals, steroids and hormo...